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ARIES® Group A Strep Assay

ARIES® Group A Strep Assay

Direct Detection of Streptococcus pyogenes Nucleic Acid in Throat Swab Specimens

ARIES® Group A Strep Assay Overview

 

Beta-hemolytic Streptococcus pyogenes, known as Group A Strep, causes strep throat, scarlet fever, and other serious health problems. Pharyngitis, the broader category into which Streptococcal pharyngitis falls, is diagnosed in 11 million people annually in the United States.1

 

Accurate diagnosis of Group A Strep is critical for appropriate treatment and mitigating unnecessary antibiotic use. The ARIES® Group A Strep Assay is a real-time PCR-based qualitative in vitro diagnostic test for the direct detection of Group A β-hemolytic Streptococcus in throat swab specimens from patients with signs and symptoms of pharyngitis. The assay is FDA cleared and CE Marked for IVD use.

 

The ARIES® Group A Strep Assay delivers higher sensitivity and specificity than existing rapid tests, and a faster turnaround time than culture methods.2

 

ARIES® Group A Strep Assay Offers:

 

  • Specificity—Identify patients with Streptococcus pyogenes infection to aid in the diagnosis of pharyngitis
  • Flexibility—Run as many as 12 tests per batch, supporting STAT testing and low- to medium-volume batch testing
  • Fast Time to Results—Answers in less than two hours with minimal hands-on time to support rapid treatment decisions
  • Full Integration—All aspects of testing are automated, from sample preparation through analysis, to enable easy implementation on weekends and night shifts
  • Error-reducing Safeguards—Internal barcode scanning matches samples to cassettes and may reduce data input errors

 

ARIES® Group A Strep Assay Performance Compared to Bacterial Culture Followed by Identification with MALDI-TOF MS

 

ARIES® Group A Strep Assay
  Bacterial Culture
Positive Negative Total
Positive 156 102 166
Negative 41 448 452
Total 160 458 6183
  95% CI  
Sensitivity 97.5% 93.7% – 99.0%
Specificity 97.8% 96.0% – 98.8%
PPV 94.0% 89.3% – 96.7%
NPV 99.1% 97.7% – 99.7%
1. Two (2) of the ARIES® Group A Strep Assay negative specimens that were positive by bacterial culture followed by identification with MALDI-TOF MS (i.e. False Negative) were Group A Strep negative by bi-directional sequencing analysis using analytically validated primers that targeted genomic regions distinct from the ARIES® Group A Strep Assay.
2. Seven (7) of the ARIES® Group A Strep Assay positive specimens that were negative by bacterial culture followed by identification with MALDI-TOF MS (i.e. False Positive) were positive by bi-directional sequencing analysis using ana- lytically validated primers that targeted genomic regions distinct from the ARIES® Group A Strep Assay.
3. Five (5) specimens generated inconclusive results by comparator culture method (MALDI-TOF MS log(score) <2.00). All five specimens were excluded from the device performance calculations.

 

Please see the Package Insert for more detailed information.

Workflow

 

The operator simply adds specimen to the sample chamber, puts the cassette in the magazine, loads the magazine into the ARIES® System, and the run will start automatically.

ARIES® Group A Strep Assay Workflow - Step 1

Step 1

Load the sample into the cassette

ARIES® Group A Strep Assay Workflow - Step 2

Step 2

Insert up to six cassettes into the magazine

ARIES® Group A Strep Assay Workflow - Step 3

Step 3

Insert the magazines into the instrument

ARIES Workflow - Step 4

Step 4

Review & release results

Ordering Information for ARIES® Group A Strep Assay

 

Luminex Online Order Management
Email: [email protected]
Phone: 1-512-336-3550
Toll Free: 1-866-401-5450
Fax: 1-512-219-0544
Fax (Europe, Middle East, India, Asia): +31 (0)73 800 1998
Product Name Kit Size Registration Status Part Number
ARIES® Group A Strep Assay
Does not include assay protocol file kit (CN-0385-01)

24 Tests US-IVD
CE Marked
50-10041
ARIES® Group A Strep Assay Protocol File Kit
(one time order only)
  US-IVD
CE Marked
CN-0385-01
ARIES® Two Module System

Includes instrument, system operation manual, two magazines, quick guide (IVD), two sample prep trays, power cord, and handheld barcode scanner and stand

1 unit US-IVD
CE Marked
ARIES-M12V1-IVD
ARIES® M1 System

Includes instrument, system operation manual, one magazine, quick guide (IVD), two sample prep trays, power cord, and handheld barcode scanner and stand

1 unit US-IVD
CE Marked
ARIES-M6V1-IVD
SYNCT™ Software   US-IVD
CE Marked
CN-SW47

ARIES® Group A Strep Resources:

 

ARIES® Group A Strep AssayProduct Sheet


ARIES®—Welcome to the New Way to WorkProduct Sheet


ARIES® M1—Welcome to the New Way to WorkProduct Sheet


Lean Labs: Delivering More with LessWhite Paper

  1. Choby BA. “Diagnosis and treatment of streptococcal pharyngitis”. Am Fam Physician. 2009 March;79(5):383–90. PMID 19275067.
  2. Pearl of Knowledge, Evidence Based Summaries: Testing for Group A Streptococcal Pharyngitis. Health Partners, Institute for Education and Research (Internet). Cited 2017 October. Available from: https://www.healthpartners.com/ucm/groups/public/@hp/@public/@ime/@content/documents/documents/cntrb_033286.pdf.

 

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.

Intended Use:

The ARIES® Group A Strep Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Streptococcus pyogenes (Group A β-hemolytic Streptococcus) in throat swab specimens from patients with signs and symptoms of pharyngitis.

The ARIES® Group A Strep Assay can be used as an aid in the diagnosis of Group A Streptococcal pharyngitis. The assay is not intended to monitor treatment for Group A Streptococcus infections.

The ARIES® Group A Strep Assay is indicated for use with the ARIES® Systems.

ARIES® Systems are class 1(I) laser products.

Validation of the LIS compatibility must be performed by the end user.